Newer-generation of Edwards transcatheter aortic valve systems: SAPIEN 3, Centera, and SAPIEN 3 Ultra

ABSTRACT

Introduction: Transcatheter aortic valve implantation (TAVI) has become the standard of care for patients with severe symptomatic aortic stenosis at moderate to high surgical risk. Newer devices are now available and broader indications are expected in the near future.

Areas covered: The Placement of Aortic Transcatheter Valves (PARTNER) trials initially proved the efficacy of TAVI with the balloon-expandable Edwards SAPIEN valve in patients deemed in-operable and at high-risk, and later on in intermediate-risk patients using the balloon-expandable SAPIEN-XT valve. These trials had laid the groundwork for advancements incorporated in the balloon-expandable SAPIEN-3 system such as the introduction of the anti-leak skirt and improved delivery system. In this review, we summarize the available data on the SAPIEN-3 transcatheter heart valve system and we highlight the special features of the newly designed self-expanding Edwards CENTERA valve, and the latest generation of balloon-expanable SAPIEN-3 Ultra™ system. A detailed literature search on these devices was undertaken using Ovid, PubMed, and Web of Science.

Expert commentary: Data from clinical trials show that TAVI with newer-generation of Edwards transcatheter heart valve systems have shown significant improvement in terms of reduced paravalvular leak and have been associated with extremely good clinical outcomes.

KEYWORDS:

• TAVI
• TAVR
• balloon-expandable
• self-expanding
• transfemoral
• transapical
• aortic stenosis

Acknowledgments

The authors want to specially thank Faouzi Kallel, PhD, Senior Director, THV Medical Affairs, Edwards Lifesciences, Irvine, California, USA, for the help in providing the images and manuscript proofreading.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.